VOLIBRIS 5 MG FILM COATED TABLET

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

AMBRISENTAN

MAH:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN:

AMBRISENTAN

units_in_package:

30Tablet Tablets

manufactured_by:

PATHEON INC

PIL

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
VOLIBRIS FILM COATED TABLET_ _
_ _
_ _
Ambrisentan (5 mg, 10 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Volibris is used for
2.
How Volibris works
3.
Before you use Volibris
4.
How to use Volibris
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Volibris
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT VOLIBRIS IS USED FOR
It is used to treat pulmonary arterial
hypertension (PAH) in adults. PAH is
high blood pressure in the blood
vessels (the pulmonary arteries) that
carry blood from the heart to the
lungs. In people with PAH, these
arteries get narrower, so the heart has
to work harder to pump blood through
them. This causes people to feel tired,
dizzy and short of breath.
HOW VOLIBRIS
WORKS
Volibris contains the active substance
ambrisentan. It belongs to a group of
medicines called other
antihypertensives (used to treat high
blood pressure). Volibris widens the
pulmonary arteries, making it easier
for the heart to pump blood through
them. This lowers the blood pressure
and relieves the symptoms.
Volibris may also be used in
combination with other medicines
used to treat PAH.
BEFORE YOU USE VOLIBRIS
-
_When you must not use it _
Do not take Volibris:
•
if you are allergic to ambrisentan,
soya, or any of the other ingredients
of this medicine. Volibris tablets
contain lecithin derived from soya.
If you are allergic to soya, do not
use this medicine.
•
if you are pregnant, if you are
planning to become pregnant, or if
you could become pregnant because
you are not using reliable birth
control (contraception)
•
if you are breast feeding
•
if you have liver disease. Talk to
your doctor, who will decide
whether this medicine is suitable for
you
•
if you have scarring of the lungs, of
unknown cause (idiopathic
pulmonary fibrosis)
Volibris is not recommended for
children and adolescents aged under
18 years as the safety and
effectiveness is not known in this age
group

SPC

CONFIDENTIAL
[GSK logo]
1. NAME OF THE MEDIC INAL PRODUCT
5 mg film -coated tablets
Volibris 5 mg film -coated tablets
10 mg film -coated tablets
Volibris 10 mg film -coated tablets
2. QUALITATIVE AND Q UANTITATIVE COMPOSIT ION
5mg film -coated tablets
Each tablet contains 5 mg of ambrisentan.
10mg film -coated tablets
Each tablet contains 10 mg of ambrisentan.
Excipient (s) with known effect:
5 mg film -coated tablets
Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin
(soya) (E322) and approximately 0.11 mg of Allura red AC Aluminium Lake (E129).
10 mg film -coated tablets
Each tablet contains approximately 90 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin
(soya) (E3 22) and approximately 0.45 mg of Allura red AC Aluminium Lake (E129).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FO RM
Film -coated tablet.
5 mg film -coated tablets
Pale -pink, square, convex, film -coated tablet with “GS” debossed on one side and “K2C” on the other
side.
10 mg film -coated tablets
Deep -pink, oval, convex, film -coated tablet with “GS” debossed on one side and “KE3” on the other side.
4. CLINICAL PARTICULARS